LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项多中心随机对照临床试验将检验旨在减肥的生活方式干预计划对几种健康结果的影响。本研究的主要目的是确定参与生活方式干预是否能有效降低超重成人2型糖尿病患者严重心血管疾病事件的发生率。其他重要的研究目标是评估减肥和健康变化对一系列疾病过程和结果的影响，并评估减肥干预的成本效益。该研究队列将包括5,000名超重（体重指数至少为25kg /m2） 2型糖尿病患者（通过自我报告验证或治疗）。全美16个中心将分别招募约313人参加试验。有或没有心血管病史的个体将被招募。参与者将根据中心进行分层，随机分配到生活方式干预组或控制干预组，糖尿病支持和教育组。生活方式干预旨在通过生活方式计划产生和维持体重减轻和增强健康，如果有必要，随后使用减肥药。这种干预包括个人和小组会议，每周举行一次会议，为期六个月，随后在试验的剩余时间内减少接触频率。糖尿病支持和教育小组将接受营养和体育活动教育以及社会支持。两组参与者都将接受与糖尿病管理相关的教育。“展望未来”的参与者将从独立于“展望未来”工作人员的医疗保健提供者那里获得一般医疗保健。参与者将每年随访至2012年，随访时间最长为11.5年。结果衡量指标包括那些可能因减肥而受到积极影响的指标（如心血管事件）和那些可能受到负面影响的指标（如骨矿物质密度）。该研究还将评估减肥可能影响心血管事件和死亡率的一些潜在机制（例如，通过改善对心血管危险因素的控制）

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Look AHEAD, multicenter, randomized controlled clinical trial will examine the impact on several health outcomes of a lifestyle intervention program designed to produce weight loss. The primary study objective is to determine whether participation in a lifestyle intervention is effective in reducing the incidence of serious cardiovascular disease events in overweight adults with type 2 diabetes. Other important study objectives are to assess the impact of weight loss and fitness changes on a range of disease processes and outcomes and to evaluate the cost-effectiveness of the weight loss intervention. The study cohort will include 5,000 overweight (body mass index of at least 25 kg/m2) individuals with type 2 diabetes (as established by self-report with verification or treatment). Sixteen centers across the United States will each recruit approximately 313 persons into the trial. Individuals with or without a prior history of cardiovascular disease will be recruited. Participants will be stratified according to center, and randomly assigned to either Lifestyle Intervention or a control intervention, Diabetes Support and Education. The Lifestyle Intervention is designed to produce and maintain weight loss and increased fitness through a lifestyle program augmented, if indicated, by subsequent use of weight loss medication. This intervention includes individual and group sessions with weekly meetings for six months followed by decreasing frequency of contact over the remainder of the trial. The Diabetes Support and Education group will receive sessions of nutrition and physical activity education and social support. Participants in both arms will receive comparable education in issues related to diabetes management. Participants in Look AHEAD will receive their general medical care from a health care provider who is separate from the Look AHEAD staff. Participants will be followed annually until 2012, resulting in a maximum of 11.5 years of participant follow-up. Outcome measures include those that might be positively affected by weight loss (e.g. cardiovascular events) and those that might be negatively affected (e.g. bone mineral density). The study will also assess some of the potential mechanisms by which weight loss may influence cardiovascular events and mortality (e.g. through improved control of cardiovascular risk factors